More than 130 batches of potassium chloride capsules, prescribed to those with hypokalaemia, have been recalled for a dissolution issue that could elevate potassium to life-threatening levels, potentially causing heart attacks.
This discovery alerted the medical community and emphasized the delicate balance required in pharmaceutical formulations.
A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland. (Photo : Sarah Silbiger/Getty Images)
FDA Announces Product Recall of Potassium Chloride Capsules
The US Food and Drug Administration (FDA) has announced the recall of 135 batches of potassium chloride extended-release capsules due to potential risks of cardiac arrest. Two brands have made the voluntary recall.
According to the FDA's June 25 press release, Glenmark Pharmaceuticals Inc. recalled 114 batches of these potassium chloride extended-release capsules, citing issues with "failed dissolution," which may lead to high potassium levels or hyperkalemia.
These capsules are typically prescribed to patients with hypokalemia or a condition marked by low potassium levels. The FDA has issued a warning that certain potassium chloride medications may not dissolve correctly, potentially raising potassium levels to dangerous levels and increasing the risk of a heart attack.
The FDA also highlighted that patients who need to use these capsules regularly are at risk of developing hyperkalemia, which can range from no symptoms to severe, life-threatening issues like cardiac arrhythmias, severe muscle weakness, and even death.
So far, the FDA noted that no cases of hyperkalemia or serious adverse events have been reported in connection with these capsules. The recalled capsules are sold in 100-count and 500-count bottles.
On behalf of BluePoint Laboratories, American Health Packaging has also recalled 21 batches of the same capsules. Glenmark Pharmaceuticals has already informed its wholesale and distributor customers through written notifications and organizes the return of all recalled batches.
The FDA has instructed wholesalers, distributors, and retailers to stop distributing the affected product lots immediately and follow the recall instructions provided. Additionally, wholesalers and distributors should carry out a sub-recall to notify retail or pharmacy customers.
The FDA advised consumers of these recalled capsules to consult their physician or healthcare provider before stopping using them or if they experience any health problems related to taking them.
The FDA's recall of potassium chloride capsules reminds us of the intricate science behind medication safety. The potential for hyperkalemia and its severe consequences have prompted immediate and decisive action from pharmaceutical companies and regulatory bodies.
Although no adverse events have been reported yet, the precautionary measures underscore the importance of vigilance in drug manufacturing and distribution. This recall highlights the FDA's crucial role in safeguarding public health and reminds us of the constant vigilance required to maintain the safety of everyday medications.
